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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, natriuretic peptide
510(k) Number K080269
Device Name TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS
Applicant
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Applicant Contact DAWN A ALLENBY
Correspondent
BIOSITE INCORPORATED
9975 SUMMERS RIDGE RD
SAN DIEGO,  CA  92121
Correspondent Contact DAWN A ALLENBY
Regulation Number862.1117
Classification Product Code
NBC  
Subsequent Product Codes
DAP   DDR   JHX   MMI  
Date Received02/01/2008
Decision Date 06/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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